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Manages the process to verify, through risk-based independent audit, compliance of PV activities with national/international regulations and guidelines on Good Pharmacovigilance...
You will lead a team of QC Microbiology Analyst’s supporting site activities related to Bioburden and Endotoxin testing of utilities, in-process, drug substance and drug product...
You will be responsible for leading global, complex extractables and leachables (E&L) projects with internal and external laboratories. You will work with site and global teams to...
Responsible for managing GCP and GVP Quality Management Systems of Research and Development activities in accordance with applicable legal, regulatory and other Quality standard...
The External Manufacturing Manager plays a pivotal role in overseeing and managing all aspects of drug product manufacturing operations. This role requires a strategic leader with...
Activities include but are not limited to, quality control of PV tasks fulfilled by DSE (EU headquarter office), EU affiliates, CROs and license partners and proactively monitors...
Guarantees cGMP compliance in all activities and systems related to Projects and Products execution. Assures that working practices are streamlined and aligned with the actual...
Ensure systems, processes and products are in compliance with cGxP, MDR and current regulatory requirements. Ensure all quality monitoring as audits, are proactively in place for...